Posted on Jan 09, 2019
The European Alliance for Personalised Medicine (EAPM) says it may seem to everyone that the whole debate on the European Commission’s proposals for enhancing EU-wide cooperation on health technology assessment (HTA) has been like sitting in a traffic jam - going nowhere fast.
EAPM hopes though, that now that we are into 2019, there will be some movement. Although, it warns, don’t expect the green light required to fully unblock the road in respect of mandatory elements of joint clinical assessments."
Despite positivity from the European Economic and Social Committee, and the backing of the European Parliament for the mandatory parts of the proposal, several Member States have objected, some raising subsidiarity concerns in an area, healthcare, that comes down to closely guarded national competence.
Meetings have been organised, discussions have been held - not least by the European Alliance for Personalised Medicine which successfully gathered stakeholders for a key roundtable in Brussels recently - but the lights remain on amber at best and the debate rumbles on.
For its part, EAPM will hold another roundtable to discuss progress on the issue in the first quarter of this year and will support the rotating presidencies - Romania and Finland - throughout 2019 as the plans hopefully begin to nudge forward.
During the latter part of 2018, the rotating presidency of the EU, Austria, worked hard to make progress, tabling a revised text, based on written and oral contributions by delegations.
A particularly important addition to the text was suggested by some delegations. This sought to define an assessment's scope.
Austria responded quickly by introducing provisions that require definitions of the content of the joint clinical assessment, or JCA, be defined. This was in respect of interventions, comparators, patient population and patient-relevant health outcomes.
On top of this, Austria worked to clarify the selection of experts to carry out JCA, transparency and confidentiality rules for participating in the joint EU work, the information to be submitted by the industry, plus the procedural steps and timelines.
But in the end, despite its best efforts, Vienna was forced to acknowledge that disagreements could not be overcome during the Austrian presidency. So now all eyes have turned to its successor Romania, which has taken on the presidency for the first time.
The Romanian presidency, already under pressure from some observers who say it is not yet fully prepared for the role, has said it is keen to avoid the political battle over mandatory versus voluntary aspects of the Commission’s HTA plans. A number of Member States are against any mandatory element on HTA(more of that later) while a larger number, plus the European Parliament, think it is necessary. A compromise seems a longway offthere is concern that it may actually be left to the Finnish presidency, which takes over in Julyafter the May elections, to finish the job.At the very least, the hope is that all will be done-and-dusted before Croatia takes over the reins on 1 January, 2020…
Romania’s health attaché Stefan Staicu hasalready said that his country wants to side-step tackling the relevant section in Article 8, and moveon to Article 9 instead, which is more concerned with timelines. Romania has essentially set its sights on a technical compromise first, followed by a political one at the end of its presidency.
It remains to be seen how much progress Romania will make before the next Health Council meeting on June 14in Luxembourg.
Towards the end of its presidency, Austria published a progress report on HTA (30 November) ahead of an EU Health Council meeting. Vienna had aimed to secure at least a partial general approach by the end of its tenure.
It’s fair to say that the country made great efforts to address concerns about mandatory uptake of JCA, but the attempt largely failed, according to its own report.
Austrian health attaché Philipp Tillich was quoted as saying: “As it turned out we had to adapt our objectives to the reality.”
He described as “unfortunate” the fact that Austrian could ultimately only release a progress report, adding that there was “a very strong political resistance from a couple of Member States”.
Tillich went on to advise Romania to “simply ignore” the heated political debate for the time being and backed the country dedicating itself to “those less tricky but also technically very important parts of the text”.
The report pointed out that Member States have already agreed that technical discussions on the Commission’s proposal will continue this year.
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